FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
72162-1594
11-digit product format
721621594
Labeler code
72162
Product ID
72162-1594_1cb3c3d3-ad1e-4c26-aa79-c38d98e21823
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078069
Marketing category
ANDA
Marketing start
2008-01-11
Substance
OXCARBAZEPINE
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OXCARBAZEPINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312137

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1594-1OXCARBAZEPINE100 in 1 BOTTLETABLET, FILM COATED100101
72162-1594-5OXCARBAZEPINE500 in 1 BOTTLETABLET, FILM COATED500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1594-1EA - Each72162-1594c121a145-c716-4698-bd87-e40bdfdee48212024-08-12
72162-1594-5EA - Each72162-15941b1076d2-0187-426d-948c-512bd442ef9912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1594OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240718_d8edaa2b-3bab-4030-a4e3-0c77f7655731.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312137OXcarbazepine 300 MG Oral TabletPSNd8edaa2b-3bab-4030-a4e3-0c77f7655731101
312137oxcarbazepine 300 MG Oral TabletSCDd8edaa2b-3bab-4030-a4e3-0c77f7655731101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1594-172162159401100 TABLET, FILM COATED in 1 BOTTLE (72162-1594-1) 2024-07-16NoNoHistorical
72162-1594-572162159405500 TABLET, FILM COATED in 1 BOTTLE (72162-1594-5) 2024-02-07NoNoHistorical